- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02887105
Memory and Emotion in Acute and Chronic Phases of Cerebrovascular Accident (MEMOIRE ET EMO)
The purpose is to determine the relationship between anxiety and cognitive performances in patients with acute and chronic phases of cerebrovascular accident (CVA). Data from neuropsychological assessment concerning cognitive processes (working and episodic memory) sensitive to different dimensions of anxiety will be analyzed.
The secondary purpose is to evaluate how some neurological (hemispherical lateralization of lesions), psychological (depression) and demographic (quality of life) variables can increase the effects of different dimensions of anxiety on cognitive processes, during the acute and/or chronic phase of CVA.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Metz, France
- Service de Neurologie - Hôpital Bon Secours - CHR de Metz-Thionville
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Nancy, France
- Service de Neurologie - Hôpital Central - CHU de Nancy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Acute phase of carotid, vertebrobasilar or lacunar cerebrovascular accident with ischemic or hemorrhagic origin
- Right-handed
- Possible cooperation: understanding of French instructions
- Normal or corrected vision
- Normal or corrected hearing
- Mini-mental state examination score higher than pathologic threshold according to age and sociocultural level of patient
- Possible follow up of patient
Exclusion Criteria:
- Hearing problems
- Vision problems
- Right hemiplegia or acute monoparesis of right upper limb
- Hemispatial neglect
- Apraxia
- Psychiatric or neurological history possibly interfering with neuropsychological evaluation
- Important defect of working memory or executive functions
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with cerebrovascular accident
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
State of anxiety evaluated with STAI-YA scale
Time Frame: up to 1 month (from CVA)
|
up to 1 month (from CVA)
|
|
State of anxiety evaluated with STAI-YA scale
Time Frame: 6 months (from CVA)
|
6 months (from CVA)
|
|
Anxiety proneness evaluated with STAI-YB scale
Time Frame: up to 1 month (from CVA)
|
up to 1 month (from CVA)
|
|
Anxiety proneness evaluated with STAI-YB scale
Time Frame: 6 months (from CVA)
|
6 months (from CVA)
|
|
Apprehension anxiety evaluated with Penn State Worry Questionnaire
Time Frame: up to 1 month (from CVA)
|
up to 1 month (from CVA)
|
|
Apprehension anxiety evaluated with Penn State Worry Questionnaire
Time Frame: 6 months (from CVA)
|
6 months (from CVA)
|
|
Evaluation of working memory updating with N-back verbal and visuospatial task
Time Frame: up to 1 month (from CVA)
|
up to 1 month (from CVA)
|
|
Evaluation of working memory updating with N-back verbal and visuospatial task
Time Frame: 6 months (from CVA)
|
6 months (from CVA)
|
|
Evaluation of working memory inhibition with Stimulus-response compatibility task
Time Frame: up to 1 month (from CVA)
|
up to 1 month (from CVA)
|
|
Evaluation of working memory inhibition with Stimulus-response compatibility task
Time Frame: 6 months (from CVA)
|
6 months (from CVA)
|
|
Evaluation of working memory flexibility with Switching task
Time Frame: up to 1 month (from CVA)
|
up to 1 month (from CVA)
|
|
Evaluation of working memory flexibility with Switching task
Time Frame: 6 months (from CVA)
|
6 months (from CVA)
|
|
Evaluation of verbal working memory with Wechsler memory scale
Time Frame: up to 1 month (from CVA)
|
up to 1 month (from CVA)
|
|
Evaluation of verbal working memory with Wechsler memory scale
Time Frame: 6 months (from CVA)
|
6 months (from CVA)
|
|
Evaluation of visuospatial working memory with Wechsler memory scale
Time Frame: up to 1 month (from CVA)
|
up to 1 month (from CVA)
|
|
Evaluation of visuospatial working memory with Wechsler memory scale
Time Frame: 6 months (from CVA)
|
6 months (from CVA)
|
|
Evaluation of visual episodic memory with Rey and Taylor figure test
Time Frame: 6 months (from CVA)
|
6 months (from CVA)
|
|
Evaluation of verbal episodic memory with RL/RI 16 item test
Time Frame: 6 months (from CVA)
|
6 months (from CVA)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hemispheric lateralization of lesions detected with MRI
Time Frame: up to 1 month from CVA
|
up to 1 month from CVA
|
|
Depression state evaluated with Back depression inventory
Time Frame: up to 1 month (from CVA)
|
up to 1 month (from CVA)
|
|
Depression state evaluated with Back depression inventory
Time Frame: 6 months (from CVA)
|
6 months (from CVA)
|
|
Quality of life evaluated with SF-36 test
Time Frame: after 6 months from CVA
|
after 6 months from CVA
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xavier DUCROCQ, Pr, Service de Neurologie - Unité Neurovasculaire - Hôpital Central Nancy
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSS2012/MEMOIRE-DUCROCQ/MS
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